DISTRESS Trial Functional Disorders - the DISTRESS Trial

Summary

A Diagnostic Clinic for Functional Somatic Disorders (FSD) has been set up at the outpatient diagnostic center at Regionshospitalet Silkeborg. The objective of the clinic is to support General Practitioners (GPs) by offering early stage diagnostic evaluation of whether a patient has an FSD or the symptoms were caused by another physical illness or mental disorder.

As a novelty in this project, Internal Medicine consultants examine the patients for FSD, after having received training in diagnosing FSD by FSD experts. By performing diagnostic evaluation for physical diseases and FSD simultaneously, the investigators believe that the new clinic shall be able to accelerate the establishment of a final diagnosis for these patients who would otherwise likely undergo a protracted diagnostic course involving sequential evaluations at various specialty clinics.

The DISTRESS trial is a pragmatic randomized clinical trial which aims to evaluate the Diagnostic Clinic for FSD in terms of clinical cost-effectiveness outcomes.

Conditions

• Bodily Distress Syndrome
• Functional Somatic Disorder

Interventions

OTHER

Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders

The intervention consists of being examined at the Diagnostic Clinic for Functional Disorders. If an FSD diagnosis is established, the patient receives feed-back of on the FSD diagnosis and patient education about the condition. Subsequently, the clinic provides guidance to the GP regarding recommended management and treatment options tailored to each individual patient.

OTHER

Diagnostic as usual

"Diagnostic as usual" consists in being referred to be examined at another existing specialist clinic in the secondary sector, as specified by the patient's GP.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Regionshospitalet Silkeborg

  lead OTHER

Principal Investigators

• Michael M Madsen, MD MPH MSc · Regionshospitalet Silkeborg

• Lise K Gormsen, MD PhD · Funktionelle Lidelser, Aarhus Universitetshospital

• Christian Trolle, MD PhD · Regionshospitalet Silkeborg

• Per Fink, MD Dr. Med PhD · Funktionelle Lidelser, Aarhus Universitetshospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-01

Primary Completion

2025-12-31

Completion

2026-09-30

Countries

• Denmark

Study Locations